Clinical Database Project Manager

Location
Frederick, MD, USA
Posted
Dec 06, 2018
Ref
req201
Hotbed
BioCapital
Required Education
Associate Degree
Position Type
Full time
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) is responsible for the management and coordination of assigned activities to Clinical Research Associates (CRAs) associated with the conduct of clinical research trials sponsored by the NIAID Intramural program.

KEY ROLES/RESPONSIBILITIES
  • Assists with the planning and implementation of clinical trials, as well as participates in managing and coordinating project activities associated with the monitoring functions of clinical studies
  • Serves as the clinical trials management (CTM) team source expert for Case Report Forms (CRF) development in FrameMaker, eCRF screens for domestic/international multi-site studies,
  • Works with CTM SMEs on TrackWise, and NIH record management system- CRIMSON
  • Creates data/monitoring plans and provides clinical research organization oversight/guidance as needed
  • Manages study activities utilizing project planning skills
  • Reviews and assists the CRAs and Principal Investigators (PIs) with the finalization of CRFs and eCRF screens
  • Serves as a clinical document lead for review and approval of study CRFs
  • Supervises staff working on study creation of eCRFs in FrameMaker
  • Works with investigators and CRAs to establish clinical monitoring plans
  • Organizes, plans, executes, reports and evaluates assigned clinical program objectives
  • Participates with CRAs in various types of study visits
  • Provides mentoring and leadership to the clinical trials management team regarding standard operating procedures (SOPs), Good Clinical Practices (GCPs), Food and Drug Administration (FDA) and International Conference Harmonization regulations governing clinical trials, daily activities and data entry related systems
  • Serves as a liaison with monitors, clinical research sites, vendors and other internal departments
  • Drafts/reviews documents such as consent form templates and study manuals
  • Assists in managing the review and approval of monitoring reports from CRAs prior to and upon completion
  • Implements periodic administrative review of SOPs for process and regulatory changes
  • Provides support for clinical report writing and annual FDA reports
  • Provides training to new CRAs on SOPs, monitoring processes, daily activities related to in-house functions, field CRA functions, and master file tracking systems
  • Performs periodic quality compliance reviews of study files and data
  • Provides project related updates/activities to study teams, government customers and colleagues
  • This position is located in Frederick, Maryland

BASIC QUALIFICATIONS:
  • Possession of a Bachelor's degree from an accredited college/university in a field related to biomedical research/clinical trials/health or four (4) years progressively responsible relevant experience based on program requirements in lieu of degree
  • Foreign degrees must be evaluated for U.S. equivalency
  • A minimum of four (4) years of progressively responsible experience directly related to overseeing multiple concurrent clinical trials that includes monitoring and clinical trials management experience
  • Extensive knowledge of clinical and outcomes research study design
  • Ability to work effectively on cross-functional teams
  • Must be detail-oriented and possess strong organizational skills with ability to prioritize multiple tasks/projects
  • Ability to work in a clinical research setting both independently and within a team
  • Ability to travel approximately 20%
  • Knowledge of clinical trial fieldwork concepts and practices
  • Must be well versed in FDA regulations and GCPs as well as other regulatory requirements and international guidelines for clinical research, with specific knowledge of monitoring requirements
  • Ability to create and maintain databases
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Certified Clinical Research Associate (CCRA) or Project Management Professional (PMP)
  • Certified IRB or clinical research professional
  • Infectious disease experience
  • Experience with FrameMaker, DataFax and TrackWise
  • Data management experience
  • Familiarity with Federal Acquisition Regulations (FARs), Department of Health and Human Services (DHHS) and NIH Policies

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)